510(k) · Cleared
ClearedHALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O&M Halyard, Inc. · FRG Wrap, Sterilization
Cleared on Sep 16, 2024 as substantially equivalent to K214007 (Owens & Minor (O&M) Halyard, Inc., 2022) after a 270-day review. Its family tree reaches back 7 generations to 1988. 2 later devices descend from it.
- Decided
- Sep 16, 2024
- Review
- 270 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881471 (1988). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 6 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 5 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 4 generations backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- 3 generations backK141712 Kimguard One Step Sterilization WrapHalyard Health · 2014
- 2 generations backK192147 Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019
- 1 generation backK214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK…Owens & Minor (O&M) Halyard, Inc. · 2022
- This deviceK234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®…O&M Halyard, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261897 HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology…O&M Halyard, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253454 HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK*…O&M Halyard, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −6 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −5 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −4 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| −3 | K141712 | Kimguard One Step Sterilization Wrap | Halyard Health | 2014 | — |
| −2 | K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019 | — |
| −1 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2022 | — |
| 0 (this device) | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization… | O&M Halyard, Inc. | 2024 | — |
| +1 | K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*… | O&M Halyard, Inc. | 2026 | — |
| +1 | K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization… | O&M Halyard, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRG device
- #1 K221875 Sterilization Pouch and Rollscore 15.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapSummary page 17…T-FOLD* Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Sterilization wrap (21 CFR 880.6850, Product Code FRG) Predicate Device: K214007 (ONE-STEP/QUICK CHECK/SEQUENTIAL Sterilization Wrap) Device Description: HALYARD SEQUENTIAL Sterilization Wrap is supplied t… | 2022 |
| † | K172191 | STERIZONE VP4 Sterilizer | 2018 |
| † | K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap… | 2024 |
| † | K192147 | Halyard ONE-STEP* Sterilization Wrap | 2019 |
| † | K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | 2019 |
| † | K143053 | KIMGUARD ONE-STEP Sterilization Wrap | 2015 |
| † | K142782 | KIMGUARD ONE-STEP Sterilization Wrap | 2015 |
| † | K141712 | Kimguard One Step Sterilization Wrap | 2014 |
| † | K140963 | Kimguard Smart-Fold Sterilization Wrap | 2014 |
| † | K141612 | Kimguard One-Step Sterilization Wrap | 2014 |
| † | K141071 | Kimguard One-Step Sterilization Wrap | 2014 |
| † | K113806 | Kimguard One Step Sterilization Wrap | 2013 |
| † | K112805 | Kimguard One-Step Sterilization Wrap | 2012 |
| † | K112300 | Kimguard Smart-Fold* Sterilization Wrap | 2012 |
| † | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 | 2009 |
| † | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 | 2009 |
| † | K082177 | Kimguard One-Step Sterilization Wrap | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K261897 (O&M Halyard, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
HALYARD* ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: • Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. • 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative…
Read the full statement (471 words)
HALYARD* ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 55°C or 12 hours at 43.3°C.
• STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles.
• STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
• STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)
• STERIS V-PRO® 1 (Lumen Cycle)
• STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)
• STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)
• STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)
• Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 300 and 30 minute dry time for Models 400, 500 and 600)
• Advanced Sterilization Products STERRAD® Sterilization System
• STERRAD® 50, 100S, and 200
• STERRAD® NX®, (Standard Cycle, Advanced Cycle)
• STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)
• STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• STERILUCENT® HC80TT Sterilization Cycles (Lumen and Flexible Cycles)
• Stryker Sterizone® VP4 Sterilizer Cycle 1
HALYARD® SMART-FOLD Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
- Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 30 minutes.
- 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/55°C or 12 hours at 110°F/43.3°C.
STERIS V-PRO® Low Temperature Sterilization Systems.
• STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
• STERIS® V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)
• STERIS® V-PRO® 1 (Lumen Cycle)
• STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)
• STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)
• STERIS® V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)
- Advanced Sterilization Products STERRAD® Sterilization System
• STERRAD® 100S
• STERRAD® NX®, (Standard Cycle, Advanced Cycle)
• STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)
• STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle)
• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234050: HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234050
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026